Cowingene HIV Detection Kit (NATBox)

ORDER INFORMATION

REF

TYPE

PACKAGE

HG05013W

mini Ⅱ

24tests/kit

INDICATION

in vitro diagnostic medical device

REGULATORY STATUS

CE-IVD

INTENDED USER

For professional use in laboratories with trained staff

TECHNOLOGY

Real-time PCR

TYPE OF ANALYSIS

Qualitative

ANALYTICAL SPECIFICITY

Human Immunodeficiency Virus

ANALYTICAL SENSITIVITY  (LoD with probability 95 %)

reaches up to 100 IU/ml with the probability of 95 % (on RNA control, GeneWell)

DYNAMIC RANGE

1E+2 ~ 1E+8 IU/ml

EXTRACTION/INHIBITION CONTROL

PCR inhibition and DNA extraction efficiency control by Internal Control (IC)

REPORTING UNITS

IU/ml

VALIDATED SPECIMEN

fresh serum

TYPE

cartridge                                 

STORAGE

2-8℃                             

SHELF LIFE

12months                              

REACTION TIME

80mins                               

DIAGNOSTIC SPECIFICITY

100.00 % (CI95%: 97.32 % – 100.00 %)     

DIAGNOSTIC SENSITIVITY

100.00 % (CI95%: 96.56 % – 100.00 %)    

APPLIED INSTRUMENTS

mini II

REQUIRED DETECTION CHANNELS

FAM, HEX，ROX，CY5